Class IIOngoingZ-1126-2026
Merit Medical Systems, Inc. recalls Merit Medical
Inflation device handle may detach from the syringe during procedure.
Merit Medical Systems,…UTJan 28, 2026
Merit Medical Systems, Inc. recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 13–24 of 25 recalls
Class IIOngoingZ-1125-2026
Merit Medical Systems, Inc. recalls Merit Medical
Inflation device handle may detach from the syringe during procedure.
Merit Medical Systems,…UTJan 28, 2026
Class IIOngoingZ-1124-2026
Merit Medical Systems, Inc. recalls Allwell Inflation Device
Inflation device handle may detach from the syringe during procedure.
Merit Medical Systems,…UTJan 28, 2026
Class IIOngoingZ-1123-2026
Merit Medical Systems, Inc. recalls Merit Medical Inflation Device.basixCOMPAK.30 atm/bar.20 mL Reference Numbers: ENDO-AN…
Inflation device handle may detach from the syringe during procedure.
Merit Medical Systems,…UTJan 28, 2026
Class IIOngoingZ-0533-2026
Merit Medical Systems, Inc. recalls PhD Hemostasis Valve
Hemostasis valve has a manufacturing defect and when used the valve cap may remain depressed, leading to potential leakage, which may result in procedure inconvenience and/or hemorrhage.
Merit Medical Systems,…UTNov 26, 2025
Class IIOngoingZ-2553-2025
Merit Medical Systems, Inc. recalls 10Fore Hemostasis Valve Catalog Number / UDI-DI code: MAPTEN4 / 00884450821305 MAPTE…
Due to a manufacturing issue involving the silicone quad ring where the ring is deformed or otherwise damaged and may cause a foreign body in the fluid pathway.
Merit Medical Systems,…UTSep 17, 2025
Class IIOngoingZ-2296-2025
Merit Medical Systems, Inc. recalls Custom Waste Management Kit: REF: K10-00353K
High pressure tubing may relax over time causing it to partially separate from the connector resulting in a void that can trap air in the line.…
Merit Medical Systems,…UTAug 20, 2025
Class IIOngoingZ-2295-2025
Merit Medical Systems, Inc. recalls Custom Manifold Kit: REF: K09-02239C
High pressure tubing may relax over time causing it to partially separate from the connector resulting in a void that can trap air in the line.…
Merit Medical Systems,…UTAug 20, 2025
Class IIOngoingZ-2294-2025
Merit Medical Systems, Inc. recalls Custom Tubing Kit: REF: K04-00417
High pressure tubing may relax over time causing it to partially separate from the connector resulting in a void that can trap air in the line.…
Merit Medical Systems,…UTAug 20, 2025
Class IIOngoingZ-2293-2025
Merit Medical Systems, Inc. recalls High Pressure Tubing: REF: 502211002
High pressure tubing may relax over time causing it to partially separate from the connector resulting in a void that can trap air in the line.…
Merit Medical Systems,…UTAug 20, 2025
Class IIOngoingZ-1641-2025
Merit Medical Systems, Inc. recalls Merit Medical
Update to IFU to provide additional information related to risk with device over-rotation and multiple deployment of fasteners.
- Gastroesophageal Reflux Disease (Gerd) Endoscopic Suture/Plication System
- Under Investigation by firm
Merit Medical Systems,…UTApr 30, 2025
Class IIOngoingZ-1640-2025
Merit Medical Systems, Inc. recalls Merit Medical
Update to IFU to provide additional information related to risk with device over-rotation and multiple deployment of fasteners.
- Gastroesophageal Reflux Disease (Gerd) Endoscopic Suture/Plication System
- Under Investigation by firm
Merit Medical Systems,…UTApr 30, 2025